Regulatory Affairs CMC Manager

2 days ago

Hyderabad, India Amgen Technology Private Limited Full time

Job Description Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: - Driving continuous improvement of processes and tools. - Ensuring awareness of processes across the organization. - Shaping the training strategy across the organization. The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job Responsibilities of the SPPM Manager include: - Support the new hire onboarding program. - Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness. - Drive consistency across Global CMC & Device Regulatory Affairs. - Develop and maintain training materials for Global CMC & Device Regulatory Affairs. - Train staff on select departmental processes and procedures. - Ensure consistent use of processes and tools across the department. - Continuous improvement of templates for presentations, timelines, trackers, and other tools. - Liaise with functions in GRAAS and Operations to ensure alignment. - Participate in cross-functional special project teams. - Potential to oversee or manage staff. What we expect of you: - We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: - Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR - Master's/Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR - Bachelor's degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry. Preferred Qualifications: Technical & Functional Expertise: - Bachelor's degree or higher in Life Sciences, Engineering, or a related field. - Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry. - Working knowledge of Regulatory CMC processes and global submission requirements. - Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs. - Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms). - Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus. Collaboration & Communication Skills: - Strong project management and organizational skills with the ability to manage multiple priorities. - Excellent written and verbal communication skills, with experience presenting to diverse audiences. - Demonstrated ability to collaborate across global, cross-functional, or matrixed teams. - Experience supporting onboarding, training, or continuous improvement initiatives. - Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency.

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